Using a Theory-based SMS/VM Intervention to Improve Sexual and Reproductive Health of Female Entertainment Workers in Cambodia: Study Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Abortion Rate
研究概览
简要总结
In Cambodia, HIV is prevalent in several high-risk groups including among female entertainment workers (FEWs) who work at entertainment venues such as karaoke bars and massage parlors and may engage in direct or indirect sex work. Reaching FEWs with sexual and reproductive health services such as testing and treatment for HIV and sexually transmitted infections (STIs) and contraception has been difficult because they are hidden and stigmatized. Mobile phone-based interventions may prove to be an effective way to reach this population and connect them with the existing services. This article describes study design and implementation of a two-arm randomized controlled trial of a mobile health intervention (the Mobile Link) aiming to improve sexual and reproductive health outcomes among FEWs in Cambodia. A two-armed randomized controlled trial (RCT) will be used to determine the effectiveness of a mobile phone-based text/voice messaging intervention. The intervention will be developed through a participatory process; 50 FEWs will work alongside researchers in focus groups to modify and tailor behavior change theory-based text and voice messages. Then, 600 FEWs will be recruited and randomly assigned into one of two arms: (1) a control group and (2) a mobile phone message group (either text messages or voice messages, delivery method chosen by participant). The primary outcome measures include HIV testing, condom use, STI testing and treatment and contraceptive use. If the Mobile Link trial is successful, an increase in condom use, screening and treatment for HIV and STI and contraception use is expected. These outcomes would lead to a reduction in the prevalence of HIV, STIs and unintended pregnancies. This trial is unique in a number of ways. First, the option of participation mode is offered to allow participants to choose the message medium that best links them to services. Second, this is the first RCT of a mobile phone-based behavior change intervention using SMS/VMs to support linkage to sexual and reproductive health services in Cambodia. Third, we are working with is a hidden, hard-to-reach and dynamic population with which traditional methods of outreach have not been fully successful.
详细描述
Introduction
Mobile phones are increasingly being used to enhance the effectiveness of health programs by engaging individuals in discreet and ongoing ways. Mobile phone health interventions, called mHealth, can also improve the availability and quality of operational research data. mHealth interventions have successfully been used in developing countries to collect health data, increase access to health knowledge and increase medication/appointment adherence. But, few mHealth interventions have been rigorously evaluated. There is strong evidence that mobile phone messages can be successfully used to support preventative healthcare, such as maternal postpartum visit attendance in Kenya. There is also evidence that self-report of risk behaviors through a mobile phone is a method of data collection that is as reliable and valid as in-person surveys. Especially for mobile or hidden populations in developing countries, mobile phones may become our most important tool for linking people to health services.
In Cambodia, several successful mobile phone-based health programs have been introduced in the areas of post-abortion contraceptive use, pharmacovigilence, diabetes self-management, case detection/notification and HIV education. The current evidence base for mobile phones used for health assessment and encouragement of the uptake of services, especially for hard-to-reach populations that face stigma and discrimination in developing countries is promising, but stronger impact evaluations are needed to understand the full benefits of such interventions.
One important hard-to-reach, high-risk group in Cambodia is the growing population of female entertainment workers (FEWs). FEWs are women working in entertainment venues such as karaoke bars, massage parlors, restaurants (as hostesses or singers) or beer gardens. FEWs frequently sell sex, directly or indirectly, to male patrons to supplement their income. By 2013, there were approximately 40,000 FEWs in Cambodia, 24,000 of whom resided in the capital city of Phnom Penh. This group has been increasing since the 2008 passage and implementation of the 'Law on Suppression of Human Trafficking and Sexual Exploitation,' which banned brothel-based sex work, and more women have moved into indirect sex work based out of entertainment venues.
The influx in the number of FEWs also follows the increase in garment factory jobs that attract young women from poor rural families to migrate to urban areas to earn and remit income to their families in their home villages. Today, the garment factories in Cambodia employ over 700,000 young women. Garment workers are typically not given fair wages, safe work environments or health insurance-a combination of factors that have resulted in worker unrests and mass fainting incidents at various factories. Claiming worker rights becomes a complicated challenge that involves risking their jobs, their livelihood and their ability to provide for family. As a result, more and more young migrant women become involved in alternative work opportunities in the entertainment industry. In addition, urban youth may also be at-risk of engaging in sex work. A recent study from Cambodia found that 48% of at-risk female youth across the country reported having been paid for sex in the past year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistical Analysis will be conducted without knowledge of the assignment of the groups.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All participants must:
- •live and work at an entertainment venue in Cambodia;
- •currently sexually active defined as engaged in oral, vaginal or anal sex in the past 3 months;
- •own their own mobile phone;
- •know how to retrieve VM or retrieve and read SMS on mobile phone (Khmer or Khmer with English alphabet);
- •self-identify as a FEW;
- •are willing to receive at most one SMS/VM per day for one year;
- •provide written informed consent and
- •agree to a follow-up visit after six months and 12 months.
排除标准
- 未提供
研究组 & 干预措施
Intervention Group
Participants in the intervention group will receive the 3 text or voice messages weekly. The messages will be designed to enhance and increase utilization of existing HIV and SRH services by reminding clients about safe sex methods available to them and providing a conduit for additional support.
干预措施: Automated text and voice messages (Other)
Control Group
Those in the control group will get one "check-in" text or voice message between baseline and midline and another between midline and endline.
结局指标
主要结局
Abortion Rate
时间窗: Past 6 months
Abortion in last six months
Gender-based violence rate
时间窗: Past 6 months
Has experienced verbal abuse such as threats of violence, physical violence, rape/sexual assault in the past six months
STI Screening
时间窗: Past six months
Sought treatment when experiencing STI symptoms in past 6 months
Recent HIV Testing
时间窗: past 6 months
Having had an HIV test in the past 6 months
Condom Use with Clients
时间窗: Past 1 month
Frequency of Condom Use with Clients in past month (always, sometime, rarely, never)
Contraceptive Prevalence Rate
时间窗: Past 1 month
Currently using modern Contraceptive method if trying to prevent pregnancy
Gender-Based harassment rate
时间窗: Past 6 months
Experienced unwanted touching or groping in the past six months
Condom Use with boyfriend/husband/romantic partner
时间窗: Past 1 month
Frequency of Condom Use with boyfriend/husband/romantic partner in past month (always, sometime, rarely, never)
Workplace Alcohol Consumption
时间窗: Past 6 months
Forced alcohol consumption at work in past six months
次要结局
未报告次要终点
